Bayh-Dole Act and difference between March-In Rights and the world wide royalty free rights in patents KEI Briefing Note 2017:1 When the United States federal government funds research that results in patents, it obtains rights, either directly or through contracts,… Continue Reading
Context and history, and areas of current work. Bayh-Dole timeline Timeline regarding Bayh-Dole march-in right requests Timeline regarding Bayh-Dole royalty-free requests Bayh-Dole Act confidentiality provisions timeline Licensing NIH owned patents and data, including KEI comments on proposed exclusive licenses, 2015… Continue Reading
KEI has asked the DHHS Office of Inspector General (OIG) to investigate a failure to disclose federal funding of patents on nusinersen, a drug developed by Ionis Pharmaceuticals (formerly known as Isis Pharmacetuicals) with BioGen, and sold under the trade name Spinraza.
A copy of the 22 page letter to OIG is available here.
Matt Richtel and Andrew Pollack explore the complex policy issues involved with the pricing of products based on taxpayer-funded inventions and research in a front page New York Times story published today.
Today, KEI submitted comments to the Notice published in the Federal Register on October 5, 2016, entitled “Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers.” KEI’s comments addressed issues with the NIH’s processes for granting exclusive licenses, and transparency in those licenses, resulting data, trials, pricing, and revenue.
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The National Institutes of Health, from 2011 through May of 2015, appears to have granted all requests for waivers of a requirement under federal law that patent holders who benefit from U.S. taxpayer-funding ensure that their patented inventions are manufactured in the United States.
The Bayh-Dole Act imposes various requirements on the grant of exclusive licenses by the patent holders of federally-funded inventions. In particular, the act generally requires that exclusive licensees “substantially” manufacture the invention in the United States.
The Act, however, also allows for the patent holder to obtain a waiver on the U.S. manufacturing requirement from the Federal agency that provided for the funding of the invention. According to a FOIA response recently obtained by Knowledge Ecology International, the NIH seems to grant every manufacturing waiver request that comes its way. Continue Reading
On September 14, 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines released its report, in which they had a mandate to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”[1]
On August 5, 2016, KEI received a response from the Department of the Army to KEI and UACT’s January 14, 2016 request that the Army and the National Institutes of Health (NIH) exercise the governments’ rights in the patents for… Continue Reading
National Institutes of Health Declines to Exercise Authority to Lower Xtandi Price
The National Institutes of Health will not use its rights under the Bayh-Dole Act to end the monopoly on the expensive prostate cancer drug Xtandi and allow low-priced generic versions to compete on the market.
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(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) On May 18th, 2016 the NIH posted a notice on the Federal Register stating it is contemplating the grant of an exclusive license to Chimeron… Continue Reading